Spinal TumorNCT05396222
A Prospective Study of the Safety and Efficacy of 3D-printed Non-rigid Biomimetic Implant in Cervical and Thoracolumbar Spine
A study testing 3D-printed custom-made non-rigid biomimetic implant in people with Spinal Tumor, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Vertebral body resection is a wide accepted procedure in tumor resection, deformity correction, and anterior decompression in spondylosis, ossification of posterior longitudinal ligaments, and spondylodiscitis surgery. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Spinal Tumor
- What is being tested?
- 3D-printed custom-made non-rigid biomimetic implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2027to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 20 - 79 years;
- Patient meet the indication for 1- to 3- level corpectomy, for primary bone tumor at spine, or metastatic tumor at spine.
- Deficit confirmed by CT, MRI, and X-ray;
- Pathology level located from C3 to L5.
- Physically and mentally able and willing to comply with the protocol;
- Signed informed consent;
- NTU Spine Multidisciplinary Board confirmed tumor excision surgery is indicated.
- Life expectancy longer than 6 months (Tokuhashi Scoring System)
Who cannot join
- Patient does not meet the indication of corpectomy, which is under the surveillance.
- More than three vertebrae required corpectomy;
- Corpectomy levels above C3 and below L5
- T-score less than -2.5
- Known allergy to device materials - such as titanium
- Any diseases or conditions that would preclude accurate clinical evaluation;
Show all 16Show fewer
- Daily, high-dose oral and/or inhaled steroid or a history of chronic use of high dose steroids;
- BMI > 35
- Life expectancy less than 6 months - (Tokuhashi Scoring System)
- The subject has received radiation therapy or chemotherapy at the trial site within one year;
- Anterior spine surgery has been received at or near the spine surgery site;
- The subject has systemic infection,or focal vertebral infection or trauma;
- The subject has endocrine disorders or metabolic disorders known to affect bone formation, such as: Paget's disease, renal osteodystrophy, hypothyroidism;
- The subject has neuromuscular diseases, those at risk of instability, implant fixation failure or postoperative care complications, including: spina bifida, cerebral palsy, and multiple sclerosis;
- Osteopenia, osteomyelitis;
- Pregnant women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
National Taiwan University Hospital
Taipei
Li YUN-HENG, 8d62535@gmail.com
About this study
Official title: A Prospective Study of the Safety and Efficacy of 3D-printed Custom-made Non-rigid Biomimetic Implant for Anterior Column Reconstruction in Cervical and Thoracolumbar Spine
Vertebral body resection is a wide accepted procedure in tumor resection, deformity correction, and anterior decompression in spondylosis, ossification of posterior longitudinal ligaments, and spondylodiscitis surgery. However, reconstruction of segmental defect is still challenging to spine surgeon, especially in 3-column resection, such as total en bloc spondylectomy in tumor patients. Various graft or prosthesis for reconstruction has been reported, such as structural allograft, Harms mesh cages, expandable cages, and carbon fiber stackable cages. There are no high evidence level study examining the superiority of those different methods.
Recently, 3D printed vertebral body replacement has been reported in different disease entities as well, such as tumor, Kümmell's disease in osteoporosis, and spondylosis. 3D printed implant comes with superiority in production of complex geometries and regularity of the fine surface detailed that promote bone ingrowth. Although, 3D-printed titanium vertebra could achieved bone integration in human, a systemic review showed that the subsidence noted in 31.4% of spine surgery with 3D printed implants. In spine surgery, the fixation construct is sufficiently stiff, interbody motion can be reduced, and loading sharing promotes bone fusion. On the other hand, if the reconstruction is too stiff, stress shielding at fusion site occurs. The concept of dynamic fusion, as opposed to rigid fusion, has been demonstrated by an anterior cervical interbody fusion study in porcine model, demonstrating good bone formation, less postfusion stiffness, and a trend to less subsidence.
Thus, we developed a 3D printed, custom-made, biomimetic prosthesis, with non-rigid structure, which has been tested in biomechanical study and porcine model, showing good bone formation and less stiffness as well. Therefore, we proposed a prospective clinical study to investigate safety, subsidence, and fusion of this prosthesis.
Read the detailed description
This is a single-arm prospective observational phase I clinical study to investigate the safety of the non-rigid 3D printed custom-made biomimetic implant. The implants are made of Titanium alloy. Patient receiving 1- to 3-level corpectomy at cervical and thoracolumbar spine. At first stage, we plan to enroll 3 cervical patients, and 3 thoracolumbar patients with non-rigid 3D printed custom-made biomimetic reconstructions. After 3 months observation after the last patients enrolled, we will conduct an interim investigation to investigate those 6 patients. if there is no re-operations due to acute post-operative reconstruction failure. We will continue the study. Total 9 cervical patients, and 9 thoracolumbar patients will be enrolled. Patients are evaluated preoperatively, right after surgery, and 1, 3, 6, 12 months postoperatively. Measure outcomes included overall success, VAS neck and back pain, patient satisfaction, anxiety score, SF-12 MCS/PCS, complications, subsequent surgery rate, and subsidence and fusion rate on radiological examination. Radiological evaluation, including X-ray and computed tomography, will be done pre-operatively, immediately after the surgery, and 1, 3, 6, 12 months postoperatively. In addition, neck disability index (NDI) will be evaluated in cervical patents, and SORGSQ 2.0 self-reported questionnaire will be applied for all oncology patients. The primary endpoint was a FDA composite definition of success comprising clinical improvement and absence of major complications and secondary surgery events.
- Conditions
- Spinal Tumor
- Being tested
- 3D-printed custom-made non-rigid biomimetic implant
- Keywords
- Spinal Tumor, Reconstruction
- Medical subject headings
- Spinal Cord Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D-printed custom-made non-rigid biomimetic implantDevice
We developed a 3D printed, custom-made, biomimetic prosthesis, with non-rigid structure, which has been tested in biomechanical study and porcine model, showing good bone formation and less stiffness as well. Therefore, we proposed a prospective clinical study to investigate safety, subsidence, and fusion of this prosthesis.
| Study group | Role | What they receive |
|---|---|---|
| 3D-printed | Experimental | We developed a 3D printed, custom-made, biomimetic prosthesis, with non-rigid structure, which has been tested in biomechanical study and porcine model, showing good bone formation and less stiffness as well. Therefore, we proposed a prospective clinical study to investigate safety, subsidence, and fusion of this prosthesis. Receives: Device: 3D-printed custom-made non-rigid biomimetic implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
We will follow up the condition of participants with treatment-related adverse events as assessed by CTCAE v4.0.
Measured: Patient were evaluated at 12 months postoperatively.
Secondary outcomes (8)
Degree of change in the subsidence
In a medical sense, subsidence refers to the collapse or settling of bone located immediately next to an implantable device in direction of the loading force. It is uasually recorded in millimeters. It was assessed on radiological examination. Radiological evaluation, including X-ray and computed tomography.
Measured: Patient were evaluated pre-operatively, immediately after the surgery, and 1, 3, 6, 12 months postoperatively.
The percentage of patients with successful fusion
The fusion rate is the percentage of patients with successful fusion over a specific range of follow up. The outcomes about fusion rate of bone was assessed on radiological examination. Radiological evaluation, including X-ray and computed tomography.
Measured: Patient were evaluated pre-operatively, immediately after the surgery, and 1, 3, 6, 12 months postoperatively.
Pain score
Pain score was assessed by Visual Analogue Scale. (0 means no pain, while 10 is the most painful situation).
Measured: Patient were evaluated pre-operatively, immediately after the surgery, and 1, 3, 6, 12 months postoperatively.
Short form-12 mental component score
The minimum value of mental component scale (MCS-12) is 18.7, and the maximum value of MCS-12 is 65.2. Higher scores mean a better outcome.
Measured: Patient were evaluated pre-operatively, immediately after the surgery, and 1, 3, 6, 12 months postoperatively.
Anxiety score
Anxiety score was assessed by Beck Anxiety Inventory (The minimum value is 0 and the maximum value is 63. A higher score means a worse outcome).
Measured: Patient were evaluated pre-operatively, immediately after the surgery, and 1, 3, 6, 12 months postoperatively.
Neck Disability Index (NDI)
Physical function was assessed by Neck Disability Index (NDI), it will be evaluated only in cervical patents.
An improvement in Neck Disability Index (NDI) score of at least 30 points for a patient with a preoperative NDI score of 60 or greater; or an improvement of at least 50% of preoperative NDI score for patients with a preoperative score of less than 60.
Measured: Patient were evaluated pre-operatively, immediately after the surgery, and 1, 3, 6, 12 months postoperatively.
Patient Satisfaction Questionnaire
Patients will be surveyed by Patient Satisfaction Questionnaire. There are two questions on the questionnaire to evaluate if they are satisfied with their treatment and if they will recommend their respective surgery to a friend.
Measured: Patient were evaluated pre-operatively, immediately after the surgery, and 1, 3, 6, 12 months postoperatively.
Short form-12 physical component score
The minimum value of physical component scale (PCS-12) is 18.4 and the maximum value of PCS-12 is 57.8.
Measured: Patient were evaluated pre-operatively, immediately after the surgery, and 1, 3, 6, 12 months postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Spinal TumorStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fon-Yih Fon-Yih, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05396222
- Sponsor's protocol ID
- 202202015DIPC
- Status last verified
- Dec 2025
- First submitted
- 4 May 2022
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bridwell KH, Lenke LG, McEnery KW, Baldus C, Blanke K. Anterior fresh frozen structural allografts in the thoracic and lumbar spine. Do they work if combined with posterior fusion and instrumentation in adult patients with kyphosis or anterior column defects? Spine (Phila Pa 1976). 1995 Jun 15;20(12):1410-8.
PubMed 7676341Lewandrowski KU, Hecht AC, DeLaney TF, Chapman PA, Hornicek FJ, Pedlow FX. Anterior spinal arthrodesis with structural cortical allografts and instrumentation for spine tumor surgery. Spine (Phila Pa 1976). 2004 May 15;29(10):1150-8; discussion 1159. doi: 10.1097/00007632-200405150-00019.
PubMed 15131446Dvorak MF, Kwon BK, Fisher CG, Eiserloh HL 3rd, Boyd M, Wing PC. Effectiveness of titanium mesh cylindrical cages in anterior column reconstruction after thoracic and lumbar vertebral body resection. Spine (Phila Pa 1976). 2003 May 1;28(9):902-8. doi: 10.1097/01.BRS.0000058712.88053.13.
PubMed 12942006Viswanathan A, Abd-El-Barr MM, Doppenberg E, Suki D, Gokaslan Z, Mendel E, Rao G, Rhines LD. Initial experience with the use of an expandable titanium cage as a vertebral body replacement in patients with tumors of the spinal column: a report of 95 patients. Eur Spine J. 2012 Jan;21(1):84-92. doi: 10.1007/s00586-011-1882-7. Epub 2011 Jun 18.
PubMed 21681631Boriani S, Biagini R, Bandiera S, Gasbarrini A, De Iure F. Reconstruction of the anterior column of the thoracic and lumbar spine with a carbon fiber stackable cage system. Orthopedics. 2002 Jan;25(1):37-42. doi: 10.3928/0147-7447-20020101-14.
PubMed 11811240Xu N, Wei F, Liu X, Jiang L, Cai H, Li Z, Yu M, Wu F, Liu Z. Reconstruction of the Upper Cervical Spine Using a Personalized 3D-Printed Vertebral Body in an Adolescent With Ewing Sarcoma. Spine (Phila Pa 1976). 2016 Jan;41(1):E50-4. doi: 10.1097/BRS.0000000000001179.
PubMed 26335676Glennie RA, Rampersaud YR, Boriani S, Reynolds JJ, Williams R, Gokaslan ZL, Schmidt MH, Varga PP, Fisher CG. A Systematic Review With Consensus Expert Opinion of Best Reconstructive Techniques After Osseous En Bloc Spinal Column Tumor Resection. Spine (Phila Pa 1976). 2016 Oct 15;41 Suppl 20:S205-S211. doi: 10.1097/BRS.0000000000001835.
PubMed 27488296Choy WJ, Mobbs RJ, Wilcox B, Phan S, Phan K, Sutterlin CE 3rd. Reconstruction of Thoracic Spine Using a Personalized 3D-Printed Vertebral Body in Adolescent with T9 Primary Bone Tumor. World Neurosurg. 2017 Sep;105:1032.e13-1032.e17. doi: 10.1016/j.wneu.2017.05.133. Epub 2017 May 31.
PubMed 28578109Wei F, Li Z, Liu Z, Liu X, Jiang L, Yu M, Xu N, Wu F, Dang L, Zhou H, Li Z, Cai H. Upper cervical spine reconstruction using customized 3D-printed vertebral body in 9 patients with primary tumors involving C2. Ann Transl Med. 2020 Mar;8(6):332. doi: 10.21037/atm.2020.03.32.
PubMed 32355776Yang X, Wan W, Gong H, Xiao J. Application of Individualized 3D-Printed Artificial Vertebral Body for Cervicothoracic Reconstruction in a Six-Level Recurrent Chordoma. Turk Neurosurg. 2020;30(1):149-155. doi: 10.5137/1019-5149.JTN.25296-18.2.
PubMed 31049920Girolami M, Boriani S, Bandiera S, Barbanti-Brodano G, Ghermandi R, Terzi S, Tedesco G, Evangelisti G, Pipola V, Gasbarrini A. Biomimetic 3D-printed custom-made prosthesis for anterior column reconstruction in the thoracolumbar spine: a tailored option following en bloc resection for spinal tumors : Preliminary results on a case-series of 13 patients. Eur Spine J. 2018 Dec;27(12):3073-3083. doi: 10.1007/s00586-018-5708-8. Epub 2018 Jul 23.
PubMed 30039254Dong C, Wei H, Zhu Y, Zhou J, Ma H. Application of Titanium Alloy 3D-Printed Artificial Vertebral Body for Stage III Kummell's Disease Complicated by Neurological Deficits. Clin Interv Aging. 2020 Dec 2;15:2265-2276. doi: 10.2147/CIA.S283809. eCollection 2020.
PubMed 33293803Wei F, Xu N, Li Z, Cai H, Zhou F, Yang J, Yu M, Liu X, Sun Y, Zhang K, Pan S, Wu F, Liu Z. A prospective randomized cohort study on 3D-printed artificial vertebral body in single-level anterior cervical corpectomy for cervical spondylotic myelopathy. Ann Transl Med. 2020 Sep;8(17):1070. doi: 10.21037/atm-19-4719.
PubMed 33145289Fang T, Zhang M, Yan J, Zhao J, Pan W, Wang X, Zhou Q. Comparative Analysis of 3D-Printed Artificial Vertebral Body Versus Titanium Mesh Cage in Repairing Bone Defects Following Single-Level Anterior Cervical Corpectomy and Fusion. Med Sci Monit. 2021 Feb 7;27:e928022. doi: 10.12659/MSM.928022.
PubMed 33550326Girolami M, Sartori M, Monopoli-Forleo D, Ghermandi R, Tedesco G, Evangelisti G, Pipola V, Pesce E, Falzetti L, Fini M, Gasbarrini A. Histological examination of a retrieved custom-made 3D-printed titanium vertebra : Do the fine details obtained by additive manufacturing really promote osteointegration? Eur Spine J. 2021 Oct;30(10):2775-2781. doi: 10.1007/s00586-021-06926-w. Epub 2021 Jul 16.
PubMed 34279722
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of the Safety and Efficacy of 3D-printed Custom-made Non-rigid Biomimetic Implant for Anterior Column Reconstruction in Cervical and Thoracolumbar Spine
- ClinicalTrials.gov ID
- NCT05396222
- Acronym / sponsor ID
- 202202015DIPC
- Conditions
- Spinal Tumor
- Keywords
- Spinal Tumor, Reconstruction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 31 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Vertebral body resection is a wide accepted procedure in tumor resection, deformity correction, and anterior decompression in spondylosis, ossification of posterior longitudinal ligaments, and spondylodiscitis surgery. However, reconstruction of segmental defect is still challenging to spine surgeon, especially in 3-column resection, such as total en bloc spondylectomy in tumor patients. Various graft or prosthesis for reconstruction has been reported, such as structural allograft, Harms mesh cages, expandable cages, and carbon fiber stackable cages. There are no high evidence level study examining the superiority of those different methods.
Recently, 3D printed vertebral body replacement has been reported in different disease entities as well, such as tumor, Kümmell's disease in osteoporosis, and spondylosis. 3D printed implant comes with superiority in production of complex geometries and regularity of the fine surface detailed that promote bone ingrowth. Although, 3D-printed titanium vertebra could achieved bone integration in human, a systemic review showed that the subsidence noted in 31.4% of spine surgery with 3D printed implants. In spine surgery, the fixation construct is sufficiently stiff, interbody motion can be reduced, and loading sharing promotes bone fusion. On the other hand, if the reconstruction is too stiff, stress shielding at fusion site occurs. The concept of dynamic fusion, as opposed to rigid fusion, has been demonstrated by an anterior cervical interbody fusion study in porcine model, demonstrating good bone formation, less postfusion stiffness, and a trend to less subsidence.
Thus, we developed a 3D printed, custom-made, biomimetic prosthesis, with non-rigid structure, which has been tested in biomechanical study and porcine model, showing good bone formation and less stiffness as well. Therefore, we proposed a prospective clinical study to investigate safety, subsidence, and fusion of this prosthesis.
Detailed description
This is a single-arm prospective observational phase I clinical study to investigate the safety of the non-rigid 3D printed custom-made biomimetic implant. The implants are made of Titanium alloy. Patient receiving 1- to 3-level corpectomy at cervical and thoracolumbar spine. At first stage, we plan to enroll 3 cervical patients, and 3 thoracolumbar patients with non-rigid 3D printed custom-made biomimetic reconstructions. After 3 months observation after the last patients enrolled, we will conduct an interim investigation to investigate those 6 patients. if there is no re-operations due to acute post-operative reconstruction failure. We will continue the study. Total 9 cervical patients, and 9 thoracolumbar patients will be enrolled. Patients are evaluated preoperatively, right after surgery, and 1, 3, 6, 12 months postoperatively. Measure outcomes included overall success, VAS neck and back pain, patient satisfaction, anxiety score, SF-12 MCS/PCS, complications, subsequent surgery rate, and subsidence and fusion rate on radiological examination. Radiological evaluation, including X-ray and computed tomography, will be done pre-operatively, immediately after the surgery, and 1, 3, 6, 12 months postoperatively. In addition, neck disability index (NDI) will be evaluated in cervical patents, and SORGSQ 2.0 self-reported questionnaire will be applied for all oncology patients. The primary endpoint was a FDA composite definition of success comprising clinical improvement and absence of major complications and secondary surgery events.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3D-printed | Experimental | Device: 3D-printed custom-made non-rigid biomimetic implantWe developed a 3D printed, custom-made, biomimetic prosthesis, with non-rigid structure, which has been tested in biomechanical study and porcine model, showing good bone formation and less stiffness as well. Therefore, we proposed a prospective clinical study to investigate safety, subsidence, and fusion of this prosthesis. |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 20 - 79 years;
- Patient meet the indication for 1- to 3- level corpectomy, for primary bone tumor at spine, or metastatic tumor at spine.
- Deficit confirmed by CT, MRI, and X-ray;
- Pathology level located from C3 to L5.
- Physically and mentally able and willing to comply with the protocol;
Key exclusion criteria (16 listed)
- Patient does not meet the indication of corpectomy, which is under the surveillance.
- More than three vertebrae required corpectomy;
- Corpectomy levels above C3 and below L5
- T-score less than -2.5
- Known allergy to device materials - such as titanium
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D-printed custom-made non-rigid biomimetic implantWe developed a 3D printed, custom-made, biomimetic prosthesis, with non-rigid structure, which has been tested in biomechanical study and porcine model, showing good bone formation and less stiffness as well. Therefore, we proposed a prospective clinical study to investigate safety, subsidence, and fusion of this prosthesis. | Device | 3D-printed |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: Patient were evaluated at 12 months postoperatively.
We will follow up the condition of participants with treatment-related adverse events as assessed by CTCAE v4.0.
8 secondary outcomes
Degree of change in the subsidence
Time frame: Patient were evaluated pre-operatively, immediately after the surgery, and 1, 3, 6, 12 months postoperatively.
The percentage of patients with successful fusion
Time frame: Patient were evaluated pre-operatively, immediately after the surgery, and 1, 3, 6, 12 months postoperatively.
Pain score
Time frame: Patient were evaluated pre-operatively, immediately after the surgery, and 1, 3, 6, 12 months postoperatively.
Short form-12 mental component score
Time frame: Patient were evaluated pre-operatively, immediately after the surgery, and 1, 3, 6, 12 months postoperatively.
Anxiety score
Time frame: Patient were evaluated pre-operatively, immediately after the surgery, and 1, 3, 6, 12 months postoperatively.
Neck Disability Index (NDI)
Time frame: Patient were evaluated pre-operatively, immediately after the surgery, and 1, 3, 6, 12 months postoperatively.
Patient Satisfaction Questionnaire
Time frame: Patient were evaluated pre-operatively, immediately after the surgery, and 1, 3, 6, 12 months postoperatively.
Short form-12 physical component score
Time frame: Patient were evaluated pre-operatively, immediately after the surgery, and 1, 3, 6, 12 months postoperatively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Results publication: PubMed 7676341Bridwell KH, Lenke LG, McEnery KW, Baldus C, Blanke K. Anterior fresh frozen structural allografts in the thoracic and lumbar spine. Do they work if combined with posterior fusion and instrumentation in adult patients with kyphosis or anterior column defects? Spine (Phila Pa 1976). 1995 Jun 15;20(12):1410-8.
- Results publication: PubMed 15131446Lewandrowski KU, Hecht AC, DeLaney TF, Chapman PA, Hornicek FJ, Pedlow FX. Anterior spinal arthrodesis with structural cortical allografts and instrumentation for spine tumor surgery. Spine (Phila Pa 1976). 2004 May 15;29(10):1150-8; discussion 1159. doi: 10.1097/00007632-200405150-00019.
- Results publication: PubMed 12942006Dvorak MF, Kwon BK, Fisher CG, Eiserloh HL 3rd, Boyd M, Wing PC. Effectiveness of titanium mesh cylindrical cages in anterior column reconstruction after thoracic and lumbar vertebral body resection. Spine (Phila Pa 1976). 2003 May 1;28(9):902-8. doi: 10.1097/01.BRS.0000058712.88053.13.
- Results publication: PubMed 21681631Viswanathan A, Abd-El-Barr MM, Doppenberg E, Suki D, Gokaslan Z, Mendel E, Rao G, Rhines LD. Initial experience with the use of an expandable titanium cage as a vertebral body replacement in patients with tumors of the spinal column: a report of 95 patients. Eur Spine J. 2012 Jan;21(1):84-92. doi: 10.1007/s00586-011-1882-7. Epub 2011 Jun 18.
- Results publication: PubMed 11811240Boriani S, Biagini R, Bandiera S, Gasbarrini A, De Iure F. Reconstruction of the anterior column of the thoracic and lumbar spine with a carbon fiber stackable cage system. Orthopedics. 2002 Jan;25(1):37-42. doi: 10.3928/0147-7447-20020101-14.
- Results publication: PubMed 26335676Xu N, Wei F, Liu X, Jiang L, Cai H, Li Z, Yu M, Wu F, Liu Z. Reconstruction of the Upper Cervical Spine Using a Personalized 3D-Printed Vertebral Body in an Adolescent With Ewing Sarcoma. Spine (Phila Pa 1976). 2016 Jan;41(1):E50-4. doi: 10.1097/BRS.0000000000001179.
- Results publication: PubMed 27488296Glennie RA, Rampersaud YR, Boriani S, Reynolds JJ, Williams R, Gokaslan ZL, Schmidt MH, Varga PP, Fisher CG. A Systematic Review With Consensus Expert Opinion of Best Reconstructive Techniques After Osseous En Bloc Spinal Column Tumor Resection. Spine (Phila Pa 1976). 2016 Oct 15;41 Suppl 20:S205-S211. doi: 10.1097/BRS.0000000000001835.
- Results publication: PubMed 28578109Choy WJ, Mobbs RJ, Wilcox B, Phan S, Phan K, Sutterlin CE 3rd. Reconstruction of Thoracic Spine Using a Personalized 3D-Printed Vertebral Body in Adolescent with T9 Primary Bone Tumor. World Neurosurg. 2017 Sep;105:1032.e13-1032.e17. doi: 10.1016/j.wneu.2017.05.133. Epub 2017 May 31.
- Results publication: PubMed 32355776Wei F, Li Z, Liu Z, Liu X, Jiang L, Yu M, Xu N, Wu F, Dang L, Zhou H, Li Z, Cai H. Upper cervical spine reconstruction using customized 3D-printed vertebral body in 9 patients with primary tumors involving C2. Ann Transl Med. 2020 Mar;8(6):332. doi: 10.21037/atm.2020.03.32.
- Results publication: PubMed 31049920Yang X, Wan W, Gong H, Xiao J. Application of Individualized 3D-Printed Artificial Vertebral Body for Cervicothoracic Reconstruction in a Six-Level Recurrent Chordoma. Turk Neurosurg. 2020;30(1):149-155. doi: 10.5137/1019-5149.JTN.25296-18.2.
- Results publication: PubMed 30039254Girolami M, Boriani S, Bandiera S, Barbanti-Brodano G, Ghermandi R, Terzi S, Tedesco G, Evangelisti G, Pipola V, Gasbarrini A. Biomimetic 3D-printed custom-made prosthesis for anterior column reconstruction in the thoracolumbar spine: a tailored option following en bloc resection for spinal tumors : Preliminary results on a case-series of 13 patients. Eur Spine J. 2018 Dec;27(12):3073-3083. doi: 10.1007/s00586-018-5708-8. Epub 2018 Jul 23.
- Results publication: PubMed 33293803Dong C, Wei H, Zhu Y, Zhou J, Ma H. Application of Titanium Alloy 3D-Printed Artificial Vertebral Body for Stage III Kummell's Disease Complicated by Neurological Deficits. Clin Interv Aging. 2020 Dec 2;15:2265-2276. doi: 10.2147/CIA.S283809. eCollection 2020.
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RecruitingPhase 3
A Study to Learn About the Investigational Drug Rinzimetostat (ORIC-944) in Patients With mCRPC Who Were Previously Treated With Abiraterone Acetate (Himalayas-1)
Metastatic Castration Resistant Prostate Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fon-Yih Fon-Yih, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D-printed custom-made non-rigid biomimetic implant in people with Spinal Tumor, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fon-Yih Fon-Yih, PhD (0933759026, 8d62535@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (time frame: Patient were evaluated at 12 months postoperatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05396222, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.